Charley Turton begins 2021 with a look ahead to the Essure sterilisation implant litigation, including in particular how it may be impacted by the damning Cumberlege review.
What is Essure?
Essure, a permanent, non-surgical birth control implant was approved by NICE and first marketed in the UK in 2009. A small coil made from polyester fibres, nickel-titanium, stainless steel, platinum and silver-tin is inserted into each fallopian tube via a catheter passed from the vagina through the cervix and uterus. Over a period of three months, the coil stimulates benign fibrotic growth (i.e. scar tissue) to form resulting in blockage of the fallopian tubes. This barrier of tissue prevents sperm from reaching the egg.
Unlike tubal ligation, which involves severing and tying the fallopian tubes, the procedure may not require a general anaesthetic (although in many cases it does). The hysteroscopic procedure is quick and minimally invasive, and in theory entails little to no pain or recovery period. This, plus the fact that Essure is non-hormonal, allowed its makers to market the implant as an attractive alternative to other forms of birth control.
Whilst intended to be irreversible, the device is capable of surgical removal.
An estimated 100,000 women in the UK have been fitted with an Essure device.
The problems with Essure
Reported issues include pain, heavy bleeding, allergic reactions to the nickel, device migration causing damage, and unplanned pregnancies resulting from the device failing.
A 2015 study by researchers at Cornell University published in the British Medical Journal found that women who received Essure implants were 10 times as likely to require a further operation in the following year as women who underwent laparoscopic sterilization. The study concluded that there was “a serious safety concern” with the Essure devices[1].
The FDA completed an extensive evaluation of medical device reports submitted in 2017 and 2018 to learn more about why women were having the device removed. The top six reported reasons in the device removal reports were pain (60%), genital haemorrhage (14%), device dislocation/migration/expulsion (12%), perforation (11%), suspected allergy to the metal component (4%) and device breakage (3%).
In September 2017, Bayer announced that it would voluntarily withdraw Essure from all non-US markets, citing “commercial reasons”[2]. Neither Bayer, nor the Medicines and Healthcare Products Regulatory Agency (MHRA), has issued a recall of the device. In 2018, Bayer made a voluntary business decision to discontinue the sales and marketing of Essure in the US, citing a decline in demand, which Bayer partly attributed to inaccurate and misleading publicity about the device.[3]
Legal action
In August 2020, Bayer announced it will settle the majority of US claims involving Essure for some $1.6 billion.
Claimant law firm PGMBM (who also represent the victims of the Mariana dam disaster in Brazil) issued a claim against Bayer in the High Court in November 2020. According to PGMBM’s website, it represents “hundreds of women from the UK and around the world”[4] in a group action based on the Consumer Protection Act 1987 (the CPA) and common law negligence. Interestingly, the website also specifies that: “Unless you have had removal surgery, or been recommended for removal surgery by your doctor, you won’t meet the eligibility criteria to make a claim.”[5]
The likely issues in the litigation include:
- Whether the safety and efficacy of Essure was properly established prior to it being approved for sale. In particular:
- The clinical trial that led to the device being approved has been criticised for not considering the long-term effects of the implants, with critics asking whether a follow-up study of one year is sufficient to establish the safety of a permanent implant.
- Others question whether the development and approval of Essure was informed by sufficient data and understanding in relation to nickel sensitivity. Essure’s own literature states that some patients may develop an allergy to nickel or other components of the insert following placement, and there is no reliable test to predict which patients may develop a reaction.
- Whether Essure carries abnormal risks to patients.
- Giving judgment in the Depuy Pinnacle Metal on Metal Hip Litigation[6] in 2018, Mrs Justice Andrews held that in order to establish liability under the CPA a claimant must show that there was an abnormal risk associated with the allegedly defective product when compared with the appropriate comparator product.
- Bayer has previously said (and is likely to argue here) that the risks associated with Essure, like pain and bleeding, were included in Essure’s labelling and the only other form of permanent contraception – tubal ligation – requires surgery and also carries significant risks.
In addition to the claim against the manufacturer, there may also be scope for individual clinical negligence actions against doctors and hospitals, which will of course be fact specific. Potential issues include negligent implantation and failure to obtain informed consent resulting from inadequate disclosure of the risks associated to the device. The latter argument seems particularly ripe, as it appears that the benefits of the device may have been overstated, possibly without due consideration being given to alternative options.
Comment
The lack of clear information regarding the existence or extent of Essure’s dangers is striking.
Bayer appear to maintain that Essure was (and is) safe, and cited misinformation and ‘misleading reports’ as the reasons for their commercial decisions to withdraw the product.
In the US, Bayer said the risk-benefit profile of Essure had not changed since its approval in 2002, and claimed that issues with the FDA’s reporting system, which allows members of the public to enter anecdotal reports, meant “it would be misleading to draw any conclusion about the cause or incidence of injuries based on adverse event reports”[7].
In the UK, a freedom of information request to the MHRA about the number of adverse events linked to Essure was reportedly rejected on the grounds that it would reveal commercially sensitive information.
The timing of the UK litigation is apt, following on from the Independent Medicines and Medical Devices Safety Review report, chaired by Baroness Cumberlege (the “Cumberlege Review”), which was published in July 2020.
The Cumberlege review examined the response of England’s healthcare system to patients’ reports of harm caused by three medicines/medical devices: hormone pregnancy tests (mainly the drug Primodos), alleged to cause serious birth defects; the anti-epileptic sodium valproate, which can cause birth defects and developmental delays; and pelvic mesh, implanted to treat organ prolapse and urinary incontinence.
The review panel heard from hundreds of patients reporting lack of informed consent for their initial treatment, followed by years of dismissal by clinicians and regulators underpinned by reluctance to acknowledge harm or unwillingness to attribute responsibility.
The review makes reference to Essure alongside other medications and devices, such as Roaccutane and PIP breast implants, and expresses regret that it could not investigate concerns arising from such products: “We believe that what we have to say and recommend for the future will have an important read-across to these and other interventions and the manner in which they are approved, delivered, regulated and monitored.” The scathing conclusions of the Cumberlege Review – which disparaged “a healthcare system that cannot be relied upon to identify and respond appropriately to healthcare concerns” – could therefore have a bearing on litigation arising from the Essure implant. The most obvious example of “read-across” will be in the context of clinical negligence actions arising from a failure in the consent process. Further points to note include the following:
- The review highlights the potential for claims against regulators as well as manufacturers. It recommends “substantial revision” of the MRHA, particularly in relation to adverse event reporting and medical device regulation. The MHRA said in September 2017, “there is currently no evidence to suggest any increased risk to patient safety”[8] from Essure and would presumably resist a claim against them on that basis. Is that correct, or should the MHRA have done more?
- The review sought expert advice on whether synthetic mesh is inherently suitable for insertion into the pelvic region but received differing opinions in response. Assuming that Bayer maintains that Essure is safe, one anticipates that claims may run into the same problem: a lack of consensus in expert opinion.
- The review recommended an ex-gratia scheme to provide need-based payments to help those affected by mesh injuries, suggesting that both the government and mesh manufacturers have an ethical obligation to contribute to the fund. Might such a fund be contemplated by the manufacturers of Essure? In light of Bayer’s denials this seems unlikely.
Finally
Product liability and clinical negligence practitioners alike will be keeping a close eye on the Essure litigation as it progresses.
In the meantime, this blog post by Henry Charles and Vanessa Cashman, which examines the issues of consent and surgical error in the context of pelvic mesh, may prove useful to those faced with bringing or defending individual claims arising from use of the Essure implant.
[1] ‘Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study’, BMJ 2015; 351(Published 13 October 2015)
[2] https://www.reuters.com/article/us-bayer-essure-fda-idUSKBN1HG2K5
[3] https://www.prnewswire.com/news-releases/bayer-reaffirms-safety-profile-of-essure-300687587.html
[4] https://essureclaimlawyers.com
[5] https://essureclaimlawyers.com
[6] Gee v DePuy International Ltd [2018] EWHC 1208 (QB)
[7] https://www.theguardian.com/society/2018/nov/25/contraceptive-implant-essure-surgically-removed-from-thousands-women
[8] https://www.gov.uk/government/news/mhra-statement-on-essure-devices
Clinical Negligence Law 